Blood Proteins in Finding Pancreatic Cancer and Extrahepatic Biliary Tract Cancer

Sponsor
National Institutes of Health Clinical Center (CC) (NIH)
Overall Status
Completed
CT.gov ID
NCT00559598
Collaborator
National Cancer Institute (NCI) (NIH)
502
56

Study Details

Study Description

Brief Summary

RATIONALE: Studying samples of blood in the laboratory from patients with cancer and from healthy participants may help doctors identify and learn more about proteins related to cancer. It may also help doctors tell whether a patient has cancer.

PURPOSE: This clinical trial is looking at proteins in blood samples to see how well they work in finding pancreatic cancer and extrahepatic biliary tract cancer.

Condition or Disease Intervention/Treatment Phase
  • Genetic: proteomic profiling
  • Other: medical chart review

Detailed Description

OBJECTIVES:
  • To explore the utility of the serum proteome pattern for early detection and diagnosis of pancreatic and extraheptic biliary tract cancer by analyzing serum samples from participants previously enrolled in the PANKRAS-II study.

  • To support efforts to contact participants (recruited to the PANKRAS-II study 10 years ago) who were diagnosed with benign biliary-pancreatic disease in order to discern if they subsequently developed a malignant biliary-pancreatic tumor.

  • To gather information about clinical factors surrounding the date of blood extraction that may influence the proteomic patterns of the blood samples by performing a review of clinical records of participants.

OUTLINE: Serum samples are analyzed for proteome pattern. Participants undergo a telephone interview about their medical history (i.e., pancreatic or biliary tract disease diagnosed within the past 10 years). Medical records are reviewed to gather information about clinical factors surrounding the date of blood extraction that may influence the proteomic patterns of the blood samples.

Study Design

Study Type:
Observational
Anticipated Enrollment :
502 participants
Official Title:
Use of Serum Proteome on the Early Diagnosis of Malignant Biliary-Pancreatic Disease
Study Start Date :
Aug 1, 2004
Actual Study Completion Date :
Apr 1, 2009

Outcome Measures

Primary Outcome Measures

  1. Utility of the serum proteome pattern for early detection and diagnosis of pancreatic cancer and extrahepatic biliary tract cancer []

  2. Contact participants (recruited to the PANKRAS-II study 10 years ago) who were diagnosed with benign biliary-pancreatic disease in order to discern if they subsequently developed a malignant biliary-pancreatic tumor []

  3. Gather information about clinical factors surrounding the date of blood extraction that may influence the proteomic patterns of the blood samples by reviewing clinical records of participants []

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
DISEASE CHARACTERISTICS:
  • Serum samples available from participants meeting any of the following criteria:

  • Diagnosis of pancreatic or extrahepatic biliary tract cancer

  • Suspected of having pancreatic or extraheptic biliary tract cancer, including pathologies (e.g., chronic pancreatitis) that might represent pre-neoplastic stages of the malignant disease

  • Healthy control

  • Previously enrolled on the PANKRAS-II study

  • Recruited to study 10 years ago

PATIENT CHARACTERISTICS:
  • Not specified
PRIOR CONCURRENT THERAPY:
  • Not specified

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • National Institutes of Health Clinical Center (CC)
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Lee E. Moore, NCI - Occupational and Environmental Epidemiology Branch

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00559598
Other Study ID Numbers:
  • 999904272
  • 04-C-N272
  • CDR0000573190
  • NCT00342979
First Posted:
Nov 16, 2007
Last Update Posted:
Mar 8, 2012
Last Verified:
Mar 1, 2012

Study Results

No Results Posted as of Mar 8, 2012